FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK ® SPIRIT COMBO
MDR report key: 4151762
·
Received October 8, 2014
Report
- Report Number
- 1823260-2014-07711
- Event Type
- Injury
- Date Received
- October 8, 2014
- Date of Event
- September 10, 2014
- Report Date
- October 28, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.
Description of Event or Problem · 1
DR. REPORTED A CUSTOMER WAS ADMITTED INTO THE HOSPITAL WITH A BLOOD GLUCOSE READING OF 1000 MG/DL; PATIENT WAS TREATED WITH INSULIN SUBCUTANEOUSLY. DR. ALLEGES THE CAUSE FOR THE ELEVATED BLOOD GLUCOSE LEVEL IS THE CUSTOMER NOT HANDLING HER PUMP THERAPY CORRECTLY. THEREFORE, THE DOCTOR STOPPED THE PUMP THERAPY. NO FURTHER DETAILS WERE PROVIDED. REQUESTED RETURN OF THE ALLEGED PUMP FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632440 | ACCU-CHEK ® SPIRIT COMBO | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |